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Diagnostic Test

DNA Methylation Testing for Thyroid Nodules

N/A
Recruiting
Led By John H Yim
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new way to test for thyroid cancer using needle biopsies. The goal is to develop a more accurate test to avoid unnecessary surgeries for benign thyroid nodules.

Who is the study for?
This trial is for adults with thyroid nodules who are undergoing needle biopsies. Participants must be able to give informed consent and have the capacity to make decisions about their healthcare. Children are excluded because the biology of their thyroid nodules differs from that of adults.Check my eligibility
What is being tested?
The study is testing a new diagnostic method using DNA methylation signatures from needle biopsy samples to distinguish between malignant (cancerous) and benign (non-cancerous) thyroid tumors, aiming to reduce unnecessary surgeries.See study design
What are the potential side effects?
Since this trial involves reviewing electronic health records and performing standard diagnostic procedures like needle biopsies, side effects may include discomfort or bruising at the biopsy site, bleeding, infection risk, and very rarely damage to nearby structures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am mentally capable and scheduled for a thyroid biopsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Negative predictive value (NPV) of DDMS-2
Positive predictive value (PPV) of DDMS-2
Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (needle biopsy, DDMS-2)Experimental Treatment3 Interventions
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,920,010 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,924,748 Total Patients Enrolled
John H YimPrincipal InvestigatorCity of Hope Medical Center

Media Library

Diagnostic Procedure (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05229341 — N/A
Thyroid Cancer Research Study Groups: Diagnostic (needle biopsy, DDMS-2)
Thyroid Cancer Clinical Trial 2023: Diagnostic Procedure Highlights & Side Effects. Trial Name: NCT05229341 — N/A
Diagnostic Procedure (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05229341 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies within this research trial for participants?

"Clinicaltrials.gov states that this clinical trial is actively enrolling patients, with the protocol first posted on October 22nd 2021 and last modified on February 4th 2022."

Answered by AI

What is the participant count for this investigation?

"Affirmative. Clinicaltrials.gov documents that this medical trial is currently recruiting for 1 site with a total of 1450 patients since its posting on October 22nd 2021 and last update on February 4th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~701 spots leftby Oct 2026